QuidelOrtho Corporation

Entity profile compiled from public source records

Public Record Profile Registrations: 14 510(k) filings: 0 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1000122536, 1000132079, 1000136573, 1000305840, 1000305841, 2024674, 2250051, 3000308930, 3002642396, 3007111389, 3012963943, 3013982035, 3021090658, 3033751096
Owner Operator Numbers 2024674
Locations Covered ATHENS, OH, US; Carlsbad, CA, US; Illkirch, CEDEX Bas-Rhin, FR; POMPANO BEACH, FL, US; Pencoed Bridgend, GB; RARITAN, NJ, US; ROCHESTER, NY, US; Rochester, NY, US; SAN DIEGO, CA, US; San Diego, CA, US; Shinagawa-ku Tokyo, JP; Singapore South West, SG

Registered Establishments (14)

Registration # Establishment Name Location Establishment Type(s) Action
1056600 MICRO TYPING SYSTEMS, INC. POMPANO BEACH, FL, US Develop Specifications But Do Not Manufacture At This Facility View Details
1319681 ORTHO-CLINICAL DIAGNOSTICS, INC. Rochester, NY, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
1319808 ORTHO-CLINICAL DIAGNOSTICS, INC. Rochester, NY, US Repack or Relabel Medical Device,Manufacture Medical Device View Details
1319809 ORTHO-CLINICAL DIAGNOSTICS, INC. ROCHESTER, NY, US Manufacture Medical Device View Details
1528450 Ortho-Clinical Diagnostics, Inc. ATHENS, OH, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
2024674 QUIDEL CORP. SAN DIEGO, CA, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
2250051 ORTHO-CLINICAL DIAGNOSTICS, INC. RARITAN, NJ, US Complaint File Establishment per 21 CFR 820.198 View Details
3000308930 Ortho-Clinical Diagnostics European Support Center Illkirch, CEDEX Bas-Rhin, FR Complaint File Establishment per 21 CFR 820.198 View Details
3002642396 Ortho Clinical Diagnostics Singapore South West, SG Complaint File Establishment per 21 CFR 820.198 View Details
3007111389 Ortho-Clinical Diagnostics Pencoed Bridgend, GB Manufacture Medical Device View Details
3012963943 Ortho Clinical Diagnostics, K.K. Shinagawa-ku Tokyo, JP Complaint File Establishment per 21 CFR 820.198 View Details
3013982035 Quidel Cardiovascular Inc. San Diego, CA, US Manufacture Device in the United States for Export Only View Details
3021090658 Ortho-Clinical Diagnostics, Inc. Carlsbad, CA, US Manufacture Medical Device View Details
3033751096 Ortho-Clinical Diagnostics, Inc. San Diego, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.

Account Required Full available specs will require a free AvaSpecs account.